Radiotherapy 12Gy in 6 Fractions For Orbital Lymphoma
ConditionOrbital Lymphoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBritish Columbia Cancer Agency
About this trial
Current standard RT doses (24-25Gy) provide excellent disease control for patients with indolent B-cell orbital lymphoma, but can cause significant late toxicities. Ultra-low dose RT (4Gy in 2 fractions) has minimal toxicity but lower disease control, requiring intensive follow-up to salvage persistent tumors. Some centers are moving towards this dose as the new standard. A recent study using 12Gy in 4 fractions to any body site showed early data suggesting high disease control rates with minimal toxicity. This study assesses 12Gy in 6 fractions, aiming to enhance disease control over 4Gy while reducing toxicity compared to 24Gy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years with stage I-IV indolent NHL*
Able to provide informed consent
Histologically confirmed indolent NHL involving one or both orbits. If bilateral, biopsy of only one orbit is permitted as long as high clinical suspicion of contralateral orbit involvement
Measurable orbital disease after biopsy, either clinically or radiographically
Disqualifiers
Aggressive NHL histology (including grade 3B follicular lymphoma)
Prior RT to orbit
Patients requiring treatments outside standard clinical hours
Systemic therapy for lymphoma is not permitted within the period of time between 2 weeks prior to RT start and 2 weeks after RT completion
Trial design
Design model
Single group
Treatments tested in this trial
External Beam Radiation Therapy
Radiation12 Gy in 6 fractions of external beam radiation therapy
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: 12 Gy in 6 fractions of external beam radiation therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Assess 2-year orbital LC after 12 Gy in 6 fractions.
Time frame
24 Months after TreatmentSecondary outcomes
1
Response rates (complete/partial/minimal response, stable/progressive disease)
Time frame
6 months and 12 months after treatment2
Evaluate orbital local control
Time frame
5 years after treatment3
Assess freedom from further in-field RT (FFRT), freedom from distant relapse (FFDR) and overall survival (OS)
Time frame
2 year and 5 year after treatment4
Health-Related Quality of Life using the EORTC QLQ-C30
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) measures health-related quality of life through 5 functional, 9 symptom, and 1 global health status scale; minimum score = 0, maximum score = 100 (for functional scales, higher is better; for symptom scales, lower is better)
Time frame
5 years after treatmentSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: